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AMRI Exec Discusses 'New Bar' in FDA Enforcement

By Zachary Brennan

- Last updated on GMT

Related tags Fda warning letter Solubility Food and drug administration Fda

Following the completion of remediation efforts to deal with an FDA warning letter, Chris Phillips, AMRI's senior director of its Burlington, Massachusetts site, discusses what he considers to be a "new bar" in enforcement activity from the agency since 2009.

Phillips also discusses how AMRI voluntarily shut down its plant in Massachusetts following an FDA warning letter from August 2010.

"It's pretty evident across the industry...the new bar which has been set with regard to FDA compliance​," Phillips said. He said his site was hit with a warning letter early on in this enforcement push, begun when FDA commissioner Margaret Hamburg took over. And now the company is able to pass on the lessons it's learned from that process to a number of its clients, he said.

New delivery technologies for poorly soluble compounds and how AMRI (Albany Molecular Research Institute) is looking to position itself in that market is another feature of this interview.

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